MSD has announced that it has been successfully granted a supplemental New Drug Application for Lynparza (olaparib), in combination with bevacizumab (sold as Avastin by Genentech) for advanced ovarian cancer, as well as being given Priority Review.
The company says that the Priority Review was based on results from the pivotal Phase III PAOLA-1 trial, in which the drug combo reduced the risk of disease progression or death by 41% based on a hazard ratio of 0.59 and improved progression-free survival (PFS) to a median of 22.1 months vs. 16.6 months compared to just bevacizumab.
Further, at two years after trial initiation, the double-blind Phase III trial found that 46% of patients treated with the combination showed no disease progression, compared to 28% of patients treated with bevacizumab alone.
The first-in-class PARP inhibitor was also recently approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, making it the first of its kind to be approved in pancreatic cancer, as well as being the drug’s third tumour type and fifth indication in the US.
Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.
Ovarian cancer is the eighth most common cause of death from cancer in women worldwide, with nearly 300,000 new cases diagnosed and around 185,000 deaths in 2018. Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%.
